New research found Abbott’s algorithm created through machine learning could give doctors a more individualized calculation, leveraging factors such as age, sex and the changing dynamics of troponin protein levels in the blood, to improve heart attack diagnosis This technology is the first machine learning developed algorithm that combines high […]
Other News
FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System
SUNNYVALE, Calif.–(BUSINESS WIRE)–EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted BreakthrouThe FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment of life-threatening or […]
InspireMD Provides Business Update
TEL AVIV, Israel, Sept. 09, 2019 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, today provided a business update. Positive CGuard™ EPS Data Presented at the Joint Congress of the World […]
Occlutech AFR Heart Failure Device Obtains CE Mark Approval
SCHAFFHAUSEN, Switzerland, Sept. 6, 2019 /PRNewswire/ — Occlutech AG announced today that its atrial flow regulator, the Occlutech AFR device, has obtained CE mark approval clearing it for sales on the European CE regulated market. Occlutech AFR is a next generation intra-atrial shunt device, intended to treat heart failure symptoms by decompressing abnormal […]
IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints
IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients DUBLIN and BARCELONA, Spain, Sept. 07, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT™ AV™ drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with […]
Vascular Therapies Announces Positive Preliminary Clinical Results from its AV Fistula Trials in Patients with Kidney Disease
CRESSKILL, N.J., Sept. 9, 2019 /PRNewswire/ — Vascular Therapies, a clinical stage biotechnology company, is developing Sirogen™, a proprietary sirolimus formulation for intraoperative local, perivascular drug delivery focused on improving vascular access outcomes in patients with kidney disease. Daniel G. Clair, MD, vascular surgeon and Chairman of the Department of Surgery at Palmetto Health-USC […]
BIOLIFE4D Becomes First U.S. Company to Successfully Demonstrate Ability to 3D Bioprint a Mini Human Heart
Pioneering biotech company reaches significant milestone, using proprietary bioink to successfully 3D bioprint a mini-heart with full structure of a whole heart, including chambers and ventricles CHICAGO, Sept. 09, 2019 (GLOBE NEWSWIRE) — BIOLIFE4D, a biotech pioneer leveraging advances in tissue engineering to 3D print human organs viable for transplant, today […]
Two new Pfizer-coauthored studies validate Novoheart’s pioneering human bioengineered heart tissues and chambers for improving drug development
September 09, 2019 00:05 ET | Source: Novoheart Holdings Inc. Novoheart seeks to revolutionize human heart tissue engineering for disease modeling and drug discovery Peer-reviewed publications feature results from the completion of two research contracts between Novoheart and Pfizer Novoheart’s proprietary MyHeartTM Platform of human bioengineered heart tissues can represent healthy as well as […]
SoniVie Receives FDA Breakthrough Device Designation for the TIVUS System in the Treatment of Pulmonary Arterial Hypertension (PAH)
– Designation facilitates more rapid approval and reimbursement for a breakthrough technology that offers significant advantages over current PAH treatment options – TEL AVIV, ISRAEL (PRWEB) SEPTEMBER 06, 2019 SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device […]
Netech Obtains FDA 510(k) Clearance for Delta 3300 – Defibrillator/Pacemaker Analyzer
FARMINGDALE, N.Y., Sept. 9, 2019 /PRNewswire/ — Leading biomedical test-instrument manufacturer Netech announced today the launch of its new state-of-the-art defibrillator/pacemaker analyzer—the Delta 3300. Recently approved by the FDA 510(k), the Delta 3300 is a precision instrument for testing and validating the functions of all semi and automated defibrillators. This revolutionary compact, […]



